Pipeline

A unique understanding of time-dependent biological processes informs everything we innovate for the treatment of chronic neurologic disorders. We continue to search for time-dependent patterns in diseases to reshape medicines and drive improved clinical outcomes for people in need.

Our medicines are timed for the benefit of patients.

ADS-5102 (amantadine) extended-release capsules

Multiple Sclerosis: Walking Impairment

Multiple sclerosis (MS) is a chronic autoimmune-mediated disorder that affects approximately 400,000 people in the United States.1 Walking impairment is a central feature of MS progression.2,3,4 The reported prevalence of impaired mobility due to MS ranges from 50% to over 90% of patients.1 As also reported in Parkinson’s disease, dysregulation of the NMDA receptor has been associated with the symptomology of MS,5 therefore symptoms may be improved by modulating overactivated NMDA receptor signaling. In addition, the impact of walking impairment and related symptoms (eg, fatigue, depression, and cognition) is most profound during the daytime when MS patients are engaged in activities of daily living.6,7 As a result, an effective treatment should provide relief beginning in the morning, and be sustained throughout the day, while not disrupting sleep.

ADS-5102, a high-dose amantadine investigational agent taken once-daily at bedtime, was designed to provide a slow initial rate-of-rise in drug concentrations and a delayed time to the maximum concentration.

We completed a Phase 2 proof-of-concept study evaluating ADS-5102 in patients with MS who have walking impairment. In the study, patients treated with ADS-5102 showed a significant improvement in walking speed as assessed by the Timed 25 Foot Walk (T25FW) test and an improvement in the Timed Up and Go (TUG). In addition, ADS-5102 was generally well tolerated.

Based on the positive Phase 2 data, we plan to initiate a pivotal registration program for this indication in the first quarter of 2018.

ADS-5102 References: 1. Sutliff, M. H. Contribution of impaired mobility to patient burden in multiple sclerosis. Curr Med Res Opin; 2010 26(1): 109-119. 2. Kurtzke, J. F. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS) and Form. Neurology; 1983 33(11):1444-1452. 3. Cohen, R. A., H. R. Kessler, et al. The Extended Disability Status Scale (EDSS) as a predictor of impairments of functional activities of daily living in multiple sclerosis. J Neurol Sci; 1993 115(2):132-135. 4. Hobart, J. C., A. Riazi, et al. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology; 2003 60(1):31-36. 5. Rossi, S., V. Studer, et al. Opposite roles of NMDA receptors in relapsing and primary progressive multiple sclerosis. PLoS One; 2013 8(6):e67357. 6. Cohen, R.A., and M. Fisher. Amantadine Treatment of Fatigue Associated with Multiple Sclerosis. Arch Neurol; 1989; 46:676-680. 7. Socie, M.J., et. al. Gait variability and disability in multiple sclerosis. Gait & Posture; 2013 38:1-55.

ADS-4101 (lacosamide)
modified-release capsules

Epilepsy: Partial-onset Seizures

Epilepsy affects an estimated 2.2 million Americans, of which 60% have partial onset seizures.1,2 Monotherapy treatment of partial seizures is effective in approximately 60% of patients, leaving the remainder of patients to require adjunctive treatment with one or more additional anticonvulsant therapies.3,4 There are limited data on the temporal distribution of seizures over the 24-hour day, however, published studies suggest that seizures occur in a diurnal pattern, characterized by a peak between 8 AM and 4 PM, and lowest between midnight and 8 AM.5 Thus, by matching the timing pattern of seizures to the concentration of the anti-epileptic drug, with a higher drug concentration during the day and lower drug concentration during the night, may enable improved seizure control.

Clinical studies of lacosamide, an anti-epilepsy active ingredient previously approved by the U.S. Food and Drug Administration (FDA) and currently marketed by UCB, Inc. as VIMPAT® (lacosamide), have reported dose limitations due to dizziness immediately following administration.6 We hypothesized the dizziness associated with higher doses might be in part attributed to the rapid initial rate-of-rise in drug concentration. Adamas scientists confirmed this time-dependent effect through in vivo modeling and preclinical experiments, showing that tolerability was dependent on rate-of-rise of drug concentration and not on maximum concentrations (Cmax).

ADS-4101, a high-dose lacosamide investigational agent taken once-daily at bedtime, was designed to have a slow initial rate-of-rise in lacosamide concentrations, to potentially improve the adverse event profile. This slow initial rise may enable a higher once-daily bedtime dose, potentially resulting in a higher daytime concentration than VIMPAT.

Data from a Phase 1 study in healthy volunteers showed that a single 400 mg dose of ADS-4101 was better tolerated compared to the equivalent dose of VIMPAT (lacosamide) immediate-release tablets. The data also demonstrated that ADS-4101 exhibited the desired pharmacokinetic properties, namely a reduced rate of initial rise and delayed time to maximum drug concentration (Tmax) appropriate for bedtime dosing.

We are currently conducting a multidose Phase 1b study designed to evaluate the tolerability and pharmacokinetic profile of three ascending doses of ADS-4101 (up to 600 mg/day) taken once-daily at bedtime compared to ascending doses of twice daily VIMPAT tablets in healthy volunteers. Topline data from the study is expected in the third quarter of 2017.

ADS-4101 References: 1. Hirtz, D., Thurman, DJ., et al. How common are the “common” neurological disorders? Neurology; 2007 68:326-337. 2. Tellez-Zenteno, JF., Ronquillo LH., et al. Discontinuation of antiepileptic drugs after successful epilepsy surgery. Epilepsy Res; 2012 102(1-2):23-33. 3. Kwan, P. B., M. J. Early identification of refractory epilepsy. N Engl J Med; 2000 42(5):314-319. 4. Brodie, M. J., S. J. Barry, et al. Patterns of treatment response in newly diagnosed epilepsy. Neurology; 2012 78(20):1548-1554. 5. Hofstra, W. A., B. E. Grootemarsink, et al. Temporal distribution of clinical seizures over the 24-h day: a retrospective observational study in a tertiary epilepsy clinic. Epilepsia; 2009 50(9):2019-2026. 6. Horstmann, R., R. Bonn, et al. Basic Clinical Pharmacologic Investigations of the New Antiepileptic Drug SPM 927. Epilepsia; 2002 43(S7).

Brand Team Leader / Sr. Director, Marketing

The Brand Team Leader / Senior Director, Marketing will be responsible for leading the ADS-5102 Brand Team, managing all aspects of marketing and launch of Adamas’ lead product, from pre-commercialization through commercialization.   Additionally, this position oversees marketing campaigns and initiatives and will collaborate with internal stakeholders to ensure that such are implemented in alignment with product goals and objectives. Additionally, this position oversees marketing campaigns and initiatives and will collaborate with internal and external stakeholders to ensure that plans are implemented in alignment with product goals and objectives. The Brand Team Leader / Senior Director, Marketing will report to the Vice President, Marketing and is based in Emeryville, CA.

Specific Responsibilities:

Qualifications:

Competencies:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

 

Clinical Supply Manager / Sr. Clinical Supply Manager

The Clinical Supply Manager has overall responsibility for the provision of clinical material supply for clinical trials and will work closely and collaboratively with their Manufacturing, CMC and Quality and Regulatory colleagues to ensure clinical trial supplies are provided for all clinical trials. This includes ensuring clinical trial supplies are labeled, packaged and distributed according to GXP requirements and trial protocol/enrollment specifications; ensuring clinical supply planning, inventory forecasting labeling, packaging and distribution is implemented to meet company goals. The Clinical Supply Manager is responsible for scheduling, management and oversight of the clinical trial supply, inventory tracking and acting as the technical lead with the clinical trial supply vendors. Ensures that all activities and operations are in accordance with internal policies and procedures and in accordance with government regulations. This position reports to the Clinical Program Director.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.
 

Medical Science Liaison

The Medical Science Liaison (MSL) is responsible for conducting medical/scientific interactions and for supporting internal activities related to medical communications, medical information and clinical research.  This position reports to the Director, Medical Science Liaison and is a field based position with a corporate headquarters in Emeryville, California.

Specific Responsibilities:

Qualifications:

To apply for this position, please click here. Principals only, no recruiters please.

 

Vice President, Quality Assurance

The Vice President, Quality Assurance will be responsible for leadership and strategic direction to ensure  Adamas’s corporate  Quality Assurance activities.  The successful candidate will be responsible for all aspects of quality assurance including regulatory inspections, vendor management, quality systems clinical and preclinical compliance, disposition of commercial product and clinical supplies.  The Vice President of Quality Assurance will be based in Emeryville, California and report to the Chief Business Officer, General Counsel & Chief Compliance Officer.

The primary focus of this position is to inspire, support and maintain a culture committed to quality in Adamas’ business activities.  Specifically, this position with the quality team will be focused on ensuring the continued maintenance and continuous improvement of key GxP processes, systems and documentation to ensure adherence to our global regulatory obligations with respect to research, clinical development, manufacturing and the availability of clinical and commercial supplies.

Specific Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.